Wednesday, December 5, 2012

A step-by-step guide to filing a complaint to the Minnesota Board of Social Work about Jean Kenney

If you are considering filing a complaint to the Minnesota
Board of Social Work about Jean Kenney and the CAFÉ or CATIE studies, here is a
guide to how you might proceed, based on Mike Howard’s successful complaint.

Start by gathering records from Fairview Hospital and/or the
Ambulatory research Center.If past
experience is an indicator, however, chances are that they will refuse your
request.Don’t be bullied; you have a
right to these records.Contact the Minnesota
Attorney General’s office and have them send a letter ordering the release of
the records to you.

You should ask for all records pertaining to your or your family
member’s medical care and the study in which they were enrolled, but here are
some special requests that you should specifically include:

- Jean Kenney’s handwritten case notes

- All CAFÉ or CATIE study visit logs

- Signed consent forms for the CAFÉ or CATIE study

- Medical records from Fairview Hospital if the patient was
hospitalized

- Records from any outside caseworker or therapist who may
have been involved

- Records of any interaction with Stephen Olson, with special
attention to how often the patient was seen by Olson

- Records of any family meeting with the study team

- Records of Kenney’s phone logs and any emails involving the
CAFÉ or CATIE study between Kenney or Olson and AstraZeneca, Quintiles, the
University of North Carolina or the National Institutes of Mental Health

Second, read the depositions by Jean Kenney
and Stephen
Olson from the lawsuit by Mary Weiss.Many of the things that are discussed in those depositions may be
relevant to your case.

Third, look at the Minnesota statutes governing social work and
see if any of them were violated in your case.If they were, cite the statutes in your letter.Statutes that might be especially relevant
include the following:

When you begin writing the complaint, here are some general
areas you might cover.

Topic 1: Medical competence

Mike Howard’s complaint successfully challenged Kenney’s
competence.The “corrective action”
found that Kenney was medical unqualified to do many of the tasks she was
assigned as study coordinator, such as dispensing study drugs and
assessingtheir side effects.You should start by looking through the
records with an eye towards answering these questions.

Did Kenney dispense a study drug to you or your family
member?

Did Kenney take a medical history or sign off on any medical
history forms?

Did Kenney sign off on any “adverse event” forms?(The phrase “adverse event” is medical jargon
for anything that goes medically wrong for a subject in a research study, such
as a side-effect from a drug or an abnormal laboratory finding.)

Did Kenney sign off on any “rating scales” for psychiatric
symptoms or drug side-effects?Examples
might include the Barnes Akathisia Rating Scale, the Simpson-Angus Scale, the
Positive and Negative Syndrome Scale (PANSS), or the Clinical Global
Impressions (CGI) scale.

Did Kenney make any mistakes about your or your family
member’s medical diagnoses, medications or dosage?

Topic 2: Informed
consent

All of the atypical antipsychotics used in the CAFÉ and
CATIE studies have been linked to hyperglycemia, diabetes, and weight
gain.During the period when the CAFÉ and
CATIE studies were in progress, the drugmakers issued warnings about these
problems to doctors and clinical investigators.All subjects in the CAFÉ and CATIE studies should have been told about
these new risks and offered the opportunity to drop out of the study or
continue.If they decided to continue,
the subjects should have been asked to sign a new consent form which included
the risks of hyperglycemia, diabetes and weight gain.

So look carefully at the informed consent form.Note whether it includes these risks.If it doesn’t -- and if it is the only
consent form in the chart -- this suggests that you or your family member was never
informed of the new risks.This is a
serious ethical breach.As the Board of
Social Work “corrective action” points out, the failure to inform subjects of
these risks would effectively invalidate their consent.

Topic 3: Privacy

The sponsors of the CAFÉ and CATIE studies did not have a legal
right to see the medical records of anyone they planned to recruit into a
research study unless that person gave them authorization by signing a HIPAA
form.(HIPAA, or the Health Information and Accountability
Act, is a federal law protecting the privacy of health information.)But the depositions from Olson and Kenney in the
lawsuit brought by Mary Weiss suggest that Olson and Kenney may not have always
asked subjects for authorization.

So be sure to look through the medical records for a signed
HIPAA form.Examine the signature
carefully and make sure that it matches that of your family member.If there are irregularities, make a note of
this in your complaint.

The “corrective action” noted that Kenney had signed
clinical documents with the initials of a physician, presumably Stephen
Olson.Look carefully through the
records of study visits and any other relevant documents to see if there is
evidence of falsification.Look at any
documents that your family member should have signed (informed consent form,
HIPAA authorization, etc.) and make sure that his or her signature is genuine.Be sure that the records of any study visits,
family meetings, etc. match up with your own records or recollections of what
happened.

Topic 5: Standard of
practice for a clinical social worker

The “corrective action” for Kenney noted a number of
instances where Kenney failed to meet minimal standards of practice for a
social worker, such as failing to respond to warnings by family members, and
the failure to document any treatment goals.Look carefully through the study records
for anything that strikes you as inadequate medical care and make a note of
them in your complaint.

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Fear and Loathing in Bioethics began life as blog for "Investigative Journalism and Bioethics," a class taught by Amy Snow Landa and Carl Elliott at the University of Minnesota. Although the class has ended, the blog has not. Most posts now are by Carl Elliott, a professor in the Center for Bioethics. However, they do not in any way represent the views or positions of the University of Minnesota.